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Carcinoid SyndromePhase 2CAMPANULANCT01018953

Study to Assess the Efficacy and Safety of Different Doses of BIM 23A760 in Patients With Carcinoid Syndrome

A Phase 2 study testing BIM 23A760 in people with Carcinoid Syndrome, run by Ipsen at 54 sites in 18 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of the protocol is to assess the efficacy and safety of BIM 23A760 on patient's overall satisfaction in terms of symptom relief (diarrhoea and/or flushes) in patients with carcinoid syndrome after 24 weeks of treatment. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Carcinoid Syndrome
What is being tested?
BIM 23A760
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
54 sitesin 18 countries
Study dates
Feb 2010to Jan 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient has a carcinoid syndrome defined as ≥3 stools/day and/or ≥3 flushes/week.
  • The patient has elevated 5-Hydroxyindoleacetic acid (above upper limit normal).
  • The patient has a well-differentiated mid-gut carcinoid tumour or serotonin secreting tumour of unknown localisation with hepatic metastasis.

Who cannot join

  • The patient has undergone surgery related to a neuroendocrine tumour (NET) within 4 weeks prior to study entry or has surgery planned during the study.
  • The patient has received short acting somatostatin analogues (SSAs) within 2 weeks before study entry or has received short acting SSAs for more than 3 months.
  • The patient has received a radiolabelled SSA at any time before study entry.
  • The patient has received long acting SSAs under certain circumstances.
  • The patient has previously received any specific anti tumour treatment such as chemotherapy, (chemo)embolisation, radiotherapy or interferon in the last 6 months.
  • The patient has signs or symptoms of cardiac insufficiency.
  • The patient has an ejection fraction <40% and/or clinically severe cardiac valvular regurgitation.

Trial locations and contacts

54 sites in 18 countries.

54 sites in 18 countries

Russia7 sites

  • Altay Regional Oncology dispensary

    Barnaul, 656052

  • Republican Clinical Oncology dispensary of the Ministry of Health of Republic of Tatarstan

    Kazan', 420111

  • Non-state Institution of Public health "Central Clinical hospital # 1, public corporation "Russian railways"

    Moscow, 125367

  • St-Petersburg State Medical University named after academician Pavlov I.P.

    Saint Petersburg, 197089

  • St-Petersburg State Institution of Public Health City Clinical Oncology dispensary

    Saint Petersburg, 198255

  • Tula Regional Oncology Dispensary

    Tula, 300053

  • Voronezh Regional Clinical Oncology Dispensary

    Voronezh, 394000

Other trials in Russia

Italy6 sites

  • Università degli Studi di Bologna, Policlinico S. Orsola-Malpighi

    Bologna, 40138

  • Istituti Ospitalieri di Cremona

    Cremona, 26100

  • Ospedale San Martino

    Genova, 16132

  • AO Universitaria Policlinico di Modena

    Modena, 41124

  • Ospedale S.Maria della Misericordia

    Perugia, 06132

  • Università degli Studi di Roma "La Sapienza", II Facoltà di Medicina e Chirurgia, Ospedale Sant'Andrea

    Roma, 00109

Other trials in Italy

France5 sites

  • Service de Gastroentérologie

    Clichy

  • Unité d'Oncologie Médicale

    Lyon, Cedex 03

  • Institut Paoli Calmette

    Marseille, 13009

  • Centre René Gauducheau

    Nantes, 44805

  • Unité de Gastro-Entérologie

    Villejuif

Other trials in France

United Kingdom5 sites

  • University Hospital Aintree

    Liverpool, L9 7AL

  • St Bartholomew's Hospital

    London, EC1A 7BE

  • Royal Free Hospital

    London, NW3 2QG

  • Christie Hospital and Holt Radium Institute

    Manchester, M20 4BX

  • Royal Preston Hospital, Sharoe Green Lane, Lancashire

    Preston, PR2 9HT

Other trials in United Kingdom

Poland4 sites

  • Centrum Onkologii Instytut im.M. Sklodowskiej-Curie oddzial w Gliwicach

    Gliwice, 44-101

  • Szpital Uniwersytecki w Krakowie

    Krakow, , 31-501

  • Instytut im Marii Sklodowskiej Curie

    Warsaw, 02-785

  • Samodzielny Publiczny Szpital Kliniczny nr 1

    Wroclaw, 50-367, 50-367

Other trials in Poland

Belgium3 sites

  • UZ Antwerpen

    Edegem, 2650

  • UZ Gent

    Ghent, 9000

  • UZ GAsthuisberg

    Leuven, 3000

Other trials in Belgium

Czechia3 sites

  • Fakultní nemocnice Hradec Králové

    Hradec Králové, 500 05

  • Fakultní nemocnice Olomouc

    Olomouc, 775 20

  • Fakultní nemocnice Na Bulovce, Ústav radiační onkologie

    Prague, 180 81

Other trials in Czechia

Germany3 sites

  • Charite Universitätsmedizin Berlin, Campus Virchow-Klinikum

    Berlin, 13353

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • Universitätsmedizin Mainz

    Mainz, 55131

Other trials in Germany

Spain3 sites

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Son Dureta

    Palma de Mallorca, 07014

Other trials in Spain

Finland2 sites

  • Helsinki Central University Hospital

    Helsinki, FIN-00029

  • Turku University Hospital

    Turku, FIN-20521

Other trials in Finland

Israel2 sites

  • Hadassah Medical Organization

    Jerusalem, 91120

  • Rabin Medical Center

    Petah Tikva, 49100

Other trials in Israel

Latvia2 sites

  • Latvian Oncology centre of Riga Eastern Clinical University Hospital

    Riga, LV-1079

  • Vidzemes Hospital

    Valmiera, LV-4201

Other trials in Latvia

Netherlands2 sites

  • UMCG

    Groningen, 9700

  • Erasmus MC

    Rotterdam, 3015

Other trials in Netherlands

Slovakia2 sites

  • Narodny onkologicky ustav

    Bratislava, 83310

  • Martinska fakultna nemocnice

    Martin, 03601

Other trials in Slovakia

Ukraine2 sites

  • Donetsk National Medical University named after M. Gorkiy, Donetsk Regional Antitumor Center

    Donetsk, 83092

  • Uzhgorod national university, Postgraduate faculty, Uzhgorod Central City Clinical Hospital

    Uzhhorod, 88000

Other trials in Ukraine

Austria1 site

  • University Hospital, Internal Medicine - Oncology

    Vienna, A-9010

Other trials in Austria

Ireland1 site

  • St James's Hospital

    Dublin

Other trials in Ireland

Sweden1 site

  • Akademiska Hospital, Dept of Oncology & Endocrinology

    Uppsala, 751 85

Other trials in Sweden

About this study

Official title: Phase II, Open, Adaptive, Dose Escalating, Multicentre Titration Study to Assess the Efficacy and Safety of Repeated Subcutaneous Administration of Different Doses of BIM 23A760 in Patients With Carcinoid Syndrome

The purpose of the protocol is to assess the efficacy and safety of BIM 23A760 on patient's overall satisfaction in terms of symptom relief (diarrhoea and/or flushes) in patients with carcinoid syndrome after 24 weeks of treatment.

Being tested
BIM 23A760
Medical subject headings
Serotonin Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BIM 23A760Drug

    BIM 23A760 is a solution at a concentration of 5 mg/mL ready for subcutaneous injection. BIM 23A760 dose of 1, 2, 4, 6 and 8 mg can be given to the patient according to a dose escalation and titration process. Patients will receive 24 weekly injections of BIM 23A760 during the treatment period. Patients eligible to continue the extension phase will be administered BIM 23A760 for further 52 weekly injections.

Study groups in NCT01018953
Study groupRoleWhat they receive
BIM 23A760ExperimentalThis dose adaptive study is planned to treat up to 20 patients in each starting dose cohort, with a maximum of three starting dose cohorts. The doses planned to be assessed are 1, 2, 4, 6 and 8 mg, however, the maximum starting dose will be 4 mg. The starting dose of the first cohort will be 1 mg; the first cohort will include at least five patients. After the first fifteen patients have been treated for 4 weeks, the results will be reviewed by a Data Review Committee. An extension phase (Part B) is planned for those subjects completing the initial study and fulfilling specific eligibility criteria (symptoms control, willingness to participate, safety and tolerability).
Receives: Drug: BIM 23A760

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Patients With a Positive Overall Satisfactory Relief of Symptoms (Diarrhoea and/or Flushes) on the Likert Scale

    Patient satisfaction based on a Likert scale from 0-5 (0 being not satisfied and 5 being completely satisfied)

    Measured: Week 24

Secondary outcomes (6)

  1. Percentage of Patients With Improvement in Symptoms (Diarrhoea and/or Flushes)

    Measured: Up to week 24

  2. Change in the Quality of Life (QoL) Assessment

    Measured: Week 24

  3. Change in 5 Hydroxyindoleacetic Acid (5 HIAA) and Chromogranin A

    Measured: Week 24

  4. Number of Subjects Reported Adverse Events, Including Any Findings From an Examination of the Injection Site(s)

    Measured: Up to week 26

  5. Minimum Concentration (Cmin) BIM 23A760 Plasma Levels

    Measured: At 9 timepoints up to 1 week after 24th administration in week 24

  6. Concentration at 2 Hours Postdose (C2 Hours) BIM 23A760 Plasma Levels

    Measured: At 8 timepoints up to week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2009 (estimated)
  2. Study startFeb 2010
  3. Primary completionDec 2010
  4. Study completionJan 2011

Why it stopped: Preliminary data from study NCT00994214 do not support expected inhibition of GH and IGF-1

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01018953
Sponsor's protocol ID
8-55-52060-004
Other IDs
2009-013222-16, 2009
Acronym
CAMPANULA
Status last verified
Nov 2020
First submitted
24 Nov 2009
Last updated
20 Nov 2020
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BIM 23A760 in people with Carcinoid Syndrome, run by Ipsen at 54 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in Russia, Italy, France, United Kingdom, Poland and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients With a Positive Overall Satisfactory Relief of Symptoms (Diarrhoea and/or Flushes) on the Likert Scale (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01018953.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.

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